Prospective, Multi-center, Non-interventional, Open Label, Randomized (Depth of Focus Testing Sequences), Clinical Study
NCT ID: NCT06767319
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
79 participants
OBSERVATIONAL
2024-12-18
2025-03-11
Brief Summary
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1. Trial lens method
2. Chart testing at appropriate focal distances (or viewing distances)
Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Testing Order
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
No intervention
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
Interventions
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No intervention
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws in U.S.;
3. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures.
4. Adults (Minimum 22 years of age or older at the time of participation in the study);
Exclusion Criteria
2. BCDVA worse than 20/32;
3. Posterior capsular opacification or other medical findings affecting best-corrected distance visual acuity (BCDVA) in the opinion of the investigator;
4. Clinically significant ocular surface disease that would affect study measurements based on investigator medical opinion;
5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
6. Known ocular disease or pathology that, in the opinion of the investigator may affect visual acuity (macular degeneration, cystoid macular edema, diabetic retinopathy, glaucoma, retinal detachment etc.);
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
22 Years
ALL
Yes
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
Responsible Party
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Locations
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Empire Eye & Laser Center
Bakersfield, California, United States
Jones Eye Center
Sioux City, Iowa, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Parkhurst NuVision
San Antonio, Texas, United States
Countries
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Other Identifiers
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MDEV110SDVA
Identifier Type: -
Identifier Source: org_study_id